The Effect of Dry Heat and Dry Cold Application on Blood Sampling in Children

NCT ID: NCT05974319

Last Updated: 2023-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-11

Study Completion Date

2021-12-29

Brief Summary

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The study was conducted as a parallel group randomized controlled in order to determine the effects of dry heat and dry cold application before blood collection in school-aged children (7-12 years old) on pain, anxiety and fear levels.

Participants were randomly assigned to experiment 1-dry hot application group, experiment 2-dry cold application group and control group.

In Experiment 1-Dry Heat Application group, a dry heat of 42°C was applied to the determined area with an electrical heating pad for 5 minutes before blood sample was taken.

In Experiment 2-Dry Cold Application group, dry cold was applied to the area determined with a gel pad for 3 minutes before blood sample was taken.

In the Control group, blood sampling was performed according to the clinical routine, and no heat or cold application was made.

Detailed Description

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Prior to blood sampling, parents and children were initially informed about the study in Experiment 1-dry heat, Experiment 2-dry cold, and control groups, and their written and verbal consents were obtained. After obtaining consent, information about the child and family was collected by the researcher with the "Child-Family Introductory Information Form" before the procedure. After the family and the child were introduced to the measurement tools (Wong Baker Faces Pain Scale, Child Fair Anxiety Scale and Medical Procedures Fear Inventory) to be scored, it was explained to the child that his mother or father would be with him during the procedure, and he was taken to the intervention room. Before the blood sample collection, the child's fear and anxiety were evaluated using Child Fear Anxiety Scale.

In Experiment 1-Dry Heat Application group, the electrical heating pad with temperature regulation was heated by the researcher and set to 42°C. After making sure that there were no contraindications (deterioration of skin integrity, etc.) in the application of the electrical heating pad device, a dry heat of 42°C was applied to the determined area with an electrical heating pad for 5 minutes.

In Experiment 2-Dry Cold Application group, dry cold was applied to the determined area with a gel pad for 3 minutes after the researcher made sure that there were no contraindications (deterioration of skin integrity, etc.) in the application of the gel pad.

In the Control group, blood sampling was performed according to the clinical routine, and no heat or cold application was made.

Conditions

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School Age Children Blood Procedural Pain Procedural Anxiety Fear

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Before blood sampling, the participants were assigned to the experiment 1-dry heat application, experiment 2-dry cold application and control groups.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control group

During the blood sample collection, the application was carried out in line with the routine care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Dry heat application

The region where the invasive intervention will be performed will be determined by the nurse in charge of the shift. The researcher will heat the thermoregulated electric pad and set it to 42°C. After making sure that there are no contraindications in the application of the electric pad device, a dry heat of 42°C will be applied to the determined area with the electric pad for 5 minutes.

Group Type EXPERIMENTAL

Dry heat application

Intervention Type OTHER

Dry heat application: The region where the invasive intervention will be performed will be determined by the nurse in charge of the shift. The researcher will heat the thermoregulated electric pad and set it to 42°C. After making sure that there are no contraindications in the application of the electric pad device, a dry heat of 42°C will be applied to the determined area with the electric pad for 5 minutes.

Dry cold application

The region where the invasive intervention will be performed will be determined by the nurse in charge of the shift. After the researcher is sure that there are no contraindications in the application of the gel pad, dry cold will be applied to the determined area with the gel pad for 3 minutes.

Group Type EXPERIMENTAL

Dry cold application

Intervention Type OTHER

Dry cold applicaiton: The region where the invasive intervention will be performed will be determined by the nurse in charge of the shift. After the researcher is sure that there are no contraindications in the application of the gel pad, dry cold will be applied to the determined area with the gel pad for 3 minutes.

Interventions

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Dry heat application

Dry heat application: The region where the invasive intervention will be performed will be determined by the nurse in charge of the shift. The researcher will heat the thermoregulated electric pad and set it to 42°C. After making sure that there are no contraindications in the application of the electric pad device, a dry heat of 42°C will be applied to the determined area with the electric pad for 5 minutes.

Intervention Type OTHER

Dry cold application

Dry cold applicaiton: The region where the invasive intervention will be performed will be determined by the nurse in charge of the shift. After the researcher is sure that there are no contraindications in the application of the gel pad, dry cold will be applied to the determined area with the gel pad for 3 minutes.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 7-12 years old
* Absence of physical and mental illness
* Absence of auditory, visual and verbal speech disability
* Parents' willingness to participate in the research, and signing the volunteer form

* Those who do not volunteer to participate
Minimum Eligible Age

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saglik Bilimleri Universitesi

OTHER

Sponsor Role lead

Responsible Party

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Berna Eren Fidancı

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Berna Eren Fidancı, RA

Role: STUDY_DIRECTOR

University of Sağlık Bilimleri

Locations

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Sağlık Bilimleri University Gulhane Training and Research Hospital

Ankara, Keçiören, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Cil M, Fidanci BE. The effect of dry heat and dry cold application on pain, anxiety and fear levels before blood sample collection in school age children (7-12 years): A randomized controlled study. J Pediatr Nurs. 2023 Nov-Dec;73:e401-e408. doi: 10.1016/j.pedn.2023.10.008. Epub 2023 Oct 19.

Reference Type DERIVED
PMID: 37863785 (View on PubMed)

Other Identifiers

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GHF_MC1

Identifier Type: -

Identifier Source: org_study_id

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